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no benefit."},{"drugId":"camrelizumab","drugName":"Camrelizumab","drugRoute":"/drugs/camrelizumab/","drugState":"approved","record":"camrelizumab","kind":"event","label":"US 2024-05: complete response letter","href":"/drugs/camrelizumab/","quote":"Complete response letter for camrelizumab + rivoceranib in HCC (manufacturing/inspection)"},{"drugId":"camrelizumab","drugName":"Camrelizumab","drugRoute":"/drugs/camrelizumab/","drugState":"approved","record":"camrelizumab","kind":"event","label":"US 2025-03: complete response letter","href":"/drugs/camrelizumab/","quote":"Second complete response letter"},{"drugId":"camrelizumab-rivoceranib","drugName":"Camrelizumab + rivoceranib","drugRoute":"/drugs/camrelizumab-rivoceranib/","drugState":"approved","record":"camrelizumab-rivoceranib","kind":"event","label":"US 2024-05: complete response letter","href":"/drugs/camrelizumab-rivoceranib/","quote":"First CRL: manufacturing inspection findings"},{"drugId":"camrelizumab-rivoceranib","drugName":"Camrelizumab + rivoceranib","drugRoute":"/drugs/camrelizumab-rivoceranib/","drugState":"approved","record":"camrelizumab-rivoceranib","kind":"event","label":"US 2025-03: complete response letter","href":"/drugs/camrelizumab-rivoceranib/","quote":"Second CRL"},{"drugId":"camrelizumab-rivoceranib","drugName":"Camrelizumab + rivoceranib","drugRoute":"/drugs/camrelizumab-rivoceranib/","drugState":"approved","record":"camrelizumab-rivoceranib","kind":"event","label":"US 2026-07-23: complete response letter","href":"https://www.targetedonc.com/view/fda-passes-again-on-approving-rivoceranib-plus-camrelizumab-in-hcc","quote":"Third CRL, again cGMP"},{"drugId":"cemiplimab","drugName":"Cemiplimab","drugRoute":"/drugs/cemiplimab/","drugState":"approved","record":"fianlimab-phase3-melanoma","kind":"trial","label":"Fianlimab + cemiplimab phase 3 (first-line melanoma): phase 3, negative","href":"/trials/fianlimab-phase3-melanoma/","quote":"Primary PFS endpoint not met; numerical +5.1 months median PFS at the high dose."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"de-escalate","kind":"trial","label":"De-ESCALaTE HPV: phase 3, negative","href":"/trials/de-escalate/","quote":"Severe toxicity similar; 2-year overall survival 97.5% (cisplatin) vs 89.4% (cetuximab)."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"rtog-0617","kind":"trial","label":"RTOG 0617: phase 3, negative","href":"/trials/rtog-0617/","quote":"Median overall survival 28.7 months (60 Gy) vs 20.3 months (74 Gy); cetuximab no benefit."},{"drugId":"cetuximab","drugName":"Cetuximab","drugRoute":"/drugs/cetuximab/","drugState":"approved","record":"rtog-1016","kind":"trial","label":"RTOG 1016: phase 3, negative","href":"/trials/rtog-1016/","quote":"5-year overall survival 84.6% (cisplatin) vs 77.9% (cetuximab); non-inferiority not met."},{"drugId":"cosibelimab","drugName":"Cosibelimab","drugRoute":"/drugs/cosibelimab/","drugState":"approved","record":"cosibelimab","kind":"event","label":"US 2023-12: complete response letter","href":"/drugs/cosibelimab/","quote":"Complete response letter citing third-party manufacturing inspection findings"},{"drugId":"durvalumab","drugName":"Durvalumab","drugRoute":"/drugs/durvalumab/","drugState":"approved","record":"calla","kind":"trial","label":"CALLA: phase 3, negative","href":"/trials/calla/","quote":"Durvalumab added to chemoradiotherapy did not significantly improve progression-free survival in locally advanced cervical cancer."},{"drugId":"durvalumab","drugName":"Durvalumab","drugRoute":"/drugs/durvalumab/","drugState":"approved","record":"dream3r","kind":"trial","label":"DREAM3R: phase 3, negative","href":"/trials/dream3r/","quote":"Stopped early; primary endpoint not met."},{"drugId":"durvalumab","drugName":"Durvalumab","drugRoute":"/drugs/durvalumab/","drugState":"approved","record":"pacific-2","kind":"trial","label":"PACIFIC-2: phase 3, negative","href":"/trials/pacific-2/","quote":"Concurrent durvalumab with chemoradiotherapy did not significantly improve progression-free survival over chemoradiotherapy alone."},{"drugId":"ipilimumab","drugName":"Ipilimumab","drugRoute":"/drugs/ipilimumab/","drugState":"approved","record":"checkmate-915","kind":"trial","label":"CheckMate 915: phase 3, negative","href":"/trials/checkmate-915/","quote":"Nivolumab plus low-dose ipilimumab did not improve recurrence-free survival over nivolumab alone after resection of stage III to IV melanoma."},{"drugId":"ipilimumab","drugName":"Ipilimumab","drugRoute":"/drugs/ipilimumab/","drugState":"approved","record":"lung-map-s1400i","kind":"trial","label":"Lung-MAP S1400I: nivolumab with or without ipilimumab: phase 3, negative","href":"/trials/lung-map-s1400i/","quote":"Nivolumab plus ipilimumab did not improve survival over nivolumab alone; the trial closed for futility."},{"drugId":"margetuximab","drugName":"Margetuximab","drugRoute":"/drugs/margetuximab/","drugState":"approved","record":"margetuximab","kind":"regional","label":"EMA / European Commission (EU): withdrawn 2022","href":"/regulatory/regions/","quote":"MAA withdrawn 2022"},{"drugId":"necitumumab","drugName":"Necitumumab","drugRoute":"/drugs/necitumumab/","drugState":"approved","record":"necitumumab","kind":"regional","label":"EMA / European Commission (EU): withdrawn 2021","href":"https://www.ema.europa.eu/en/medicines/human/EPAR/portrazza","quote":"Portrazza authorised 15 Feb 2016; Lilly did not apply for renewal and the authorisation expired 18 Feb 2021 (lack of demand)"},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-143","kind":"trial","label":"CheckMate 143: phase 3, negative","href":"/trials/checkmate-143/","quote":"OS 9.8 vs 10.0 months, HR 1.04 (95% CI 0.83-1.30); no benefit."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-498","kind":"trial","label":"CheckMate 498: phase 3, negative","href":"/trials/checkmate-498/","quote":"OS 13.4 vs 14.9 months, HR 1.31 (95% CI 1.09-1.58); worse with nivolumab."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-548","kind":"trial","label":"CheckMate 548: phase 3, negative","href":"/trials/checkmate-548/","quote":"OS 28.9 vs 32.1 months, HR 1.1 (95% CI 0.9-1.3); no PFS or OS benefit."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"checkmate-915","kind":"trial","label":"CheckMate 915: phase 3, negative","href":"/trials/checkmate-915/","quote":"Nivolumab plus low-dose ipilimumab did not improve recurrence-free survival over nivolumab alone after resection of stage III to IV melanoma."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"lung-map-s1400i","kind":"trial","label":"Lung-MAP S1400I: nivolumab with or without ipilimumab: phase 3, negative","href":"/trials/lung-map-s1400i/","quote":"Nivolumab plus ipilimumab did not improve survival over nivolumab alone; the trial closed for futility."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"relativity-098","kind":"trial","label":"RELATIVITY-098: phase 3, negative","href":"/trials/relativity-098/","quote":"RFS not improved."},{"drugId":"nivolumab","drugName":"Nivolumab","drugRoute":"/drugs/nivolumab/","drugState":"approved","record":"tinivo-2","kind":"trial","label":"TiNivo-2: phase 3, negative","href":"/trials/tinivo-2/","quote":"PFS HR 1.10; no benefit from nivolumab rechallenge."},{"drugId":"ofatumumab","drugName":"Ofatumumab","drugRoute":"/drugs/ofatumumab/","drugState":"approved","record":"ofatumumab","kind":"regional","label":"EMA / European Commission (EU): withdrawn 2019","href":"https://www.ema.europa.eu/en/medicines/human/EPAR/arzerra","quote":"Arzerra authorised 19 Apr 2010; marketing authorisation withdrawn at Novartis's request 28 Feb 2019 (commercial reasons)"},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"fianlimab-phase3-melanoma","kind":"trial","label":"Fianlimab + cemiplimab phase 3 (first-line melanoma): phase 3, negative","href":"/trials/fianlimab-phase3-melanoma/","quote":"Primary PFS endpoint not met; numerical +5.1 months median PFS at the high dose."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"impassion131","kind":"trial","label":"IMpassion131: phase 3, negative","href":"/trials/impassion131/","quote":"PFS HR 0.82 (not significant); OS trend unfavourable; US indication withdrawn 2021."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"keynote-412","kind":"trial","label":"KEYNOTE-412: phase 3, negative","href":"/trials/keynote-412/","quote":"Pembrolizumab added to chemoradiotherapy did not significantly improve event-free survival."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"leap-002","kind":"trial","label":"LEAP-002: phase 3, negative","href":"/trials/leap-002/","quote":"OS HR 0.84, not significant."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"litespark-012","kind":"trial","label":"LITESPARK-012: phase 3, negative","href":"/trials/litespark-012/","quote":"Primary endpoint not met (ASCO GU 2026)."},{"drugId":"pembrolizumab","drugName":"Pembrolizumab","drugRoute":"/drugs/pembrolizumab/","drugState":"approved","record":"nct05117242","kind":"trial","label":"Safety and Efficacy Study of GEN1046 as a Single Agent or in Combination With Pembrolizumab for Treatment of Recurrent (Non-small Cell) Lung Cancer: phase 2, terminated or withdrawn","href":"/trials/nct05117242/","quote":"Genmab has decided to discontinue further clinical development of acasunlimab following strategic portfolio prioritization. The decision was not related to safety concerns."},{"drugId":"pertuzumab","drugName":"Pertuzumab","drugRoute":"/drugs/pertuzumab/","drugState":"approved","record":"kristine","kind":"trial","label":"KRISTINE: phase 3, negative","href":"/trials/kristine/","quote":"Pathological complete response 44.4% (T-DM1 + pertuzumab) vs 55.7% (TCHP); more locoregional progression before surgery with T-DM1."},{"drugId":"relatlimab-nivolumab","drugName":"Relatlimab + nivolumab","drugRoute":"/drugs/relatlimab-nivolumab/","drugState":"approved","record":"relativity-098","kind":"trial","label":"RELATIVITY-098: phase 3, negative","href":"/trials/relativity-098/","quote":"RFS not improved."},{"drugId":"sintilimab","drugName":"Sintilimab","drugRoute":"/drugs/sintilimab/","drugState":"approved","record":"sintilimab","kind":"regional","label":"FDA (US): rejected 2022","href":"/regulatory/regions/","quote":"CRL Mar 2022 for ORIENT-11 (single-country trial); ODAC 14 to 1"},{"drugId":"sintilimab","drugName":"Sintilimab","drugRoute":"/drugs/sintilimab/","drugState":"approved","record":"sintilimab","kind":"event","label":"US 2022-03: complete response letter","href":"https://web.archive.org/web/20250302091714/https://www.fda.gov/advisory-committees/advisory-committee-calendar/february-10-2022-meeting-oncologic-drugs-advisory-committee-meeting-announcement-02102022","quote":"Complete response letter for ORIENT-11 (first-line non-squamous NSCLC); ODAC voted 14 to 1 that additional data were needed for US applicability"},{"drugId":"trastuzumab","drugName":"Trastuzumab","drugRoute":"/drugs/trastuzumab/","drugState":"approved","record":"kristine","kind":"trial","label":"KRISTINE: phase 3, negative","href":"/trials/kristine/","quote":"Pathological complete response 44.4% (T-DM1 + pertuzumab) vs 55.7% (TCHP); more locoregional progression before surgery with T-DM1."}],"proposed":[],"note":"Every state is derived from the records named in evidence; untried means no medicine in this corpus combines the two parts. Proposed cells are hypotheses from the open pipeline (docs/OPEN-PIPELINE.md), not records of a medicine. CC BY-NC 4.0, attribute Data from OnCo (onco.cc). Not medical advice."}